EMA Pilots Early Interaction Meetings to Speed Pediatric Drug Development
Hoping to speed development of new treatments for children, the European Medicines Agency is offering drugmakers free meetings with members of its Paediatric Committee.
The one-year pilot, launched last week, aims to get discussions moving on pediatric needs that could be addressed by a specific drug long before a company submits a detailed pediatric investigation plan.
Sponsors should submit a request, including a briefing document, at least two months before the desired meeting date. An EMA pediatric coordinator and Paediatric Committee member will be assigned to review the request and assign a time for the meeting, which may include staff from European member state authorities as well.
Medicines for rare diseases or those filling a high pediatric need will be given preference, the EMA says. The agency will review the program at the end of one year and modify it, if needed.
The EMA decided to conduct the pilot after noting that many adult and pediatric drug development plans aren’t well-integrated and opportunities for extrapolating results of clinical trials in adults to children aren’t always fully explored.
Information on how to apply for the pilot is available at www.fdanews.com/06-17-15-pediatric.pdf. — Meg Bryant